New safety warnings added to abortion pill

By The Associated Press

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WASHINGTON — New warnings will be added to an abortion pill implicated in the death of an 18-year-old California woman last fall, linking Mifeprex to the risk of serious bacterial infection.

Holly Patterson died Sept. 17, 2003, of septic shock caused by inflammation of the uterus. She died weeks after taking Mifeprex to terminate an unplanned pregnancy.

Mifeprex is the brand name of mifepristone, also called RU-486, sold in the United States.

The Food and Drug Administration (FDA) approved Mifeprex in 2000 to terminate pregnancy up to 49 days after the beginning of the last menstrual cycle. The drug blocks progesterone, a hormone required to sustain a pregnancy. When followed by another medicine, misoprostol, Mifeprex terminates the pregnancy.

Anti-abortion activists seized upon Patterson's death in their campaign against these pills.

Mifeprex already carries a black box warning, the agency's most strident alert, to highlight other safety concerns. The FDA said yesterday that the drug's black-box warning will be expanded, adding information about the rare but potentially life-threatening complications, such as serious bacterial infections and bleeding, that can follow any abortion, including one induced by Mifeprex.

Since the drug was approved, the agency has received reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured and death.

Serious bacterial infection may happen silently, without typical signs of infection such as fever or tenderness, the label warns. The revised label also cautions health-care providers that prolonged, heavy bleeding may warrant surgical intervention.

Women who have taken the drug should contact a doctor immediately if they suffer fever, abdominal pain and heavy bleeding, a medication guide aimed at consumers says. And the FDA counsels women to take their medication guide to any health-care provider they visit to speed treatment.

Danco Laboratories, which make Mifeprex, did not immediately return a phone call seeking comment. In an earlier statement, the company said 200,000 U.S. women and more than 1 million women worldwide have used the pill since it was invented in France in the 1980s.

At least two other U.S. women who took the pill died, although the FDA says it is unclear if their deaths were directly related to the pill's use.

Copyright © 2004 The Seattle Times Company

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